This July, GE Healthcare announced the opening of a Cell & Gene Therapy Asia Technology Center in Shanghai. This center will include dedicated space for cell and gene therapy development, offering support for biopharma and biotech companies in research and technology development, process development, small to medium scale manufacturing, and training in Asia. Moreover, it means patients are closer to receiving the precision medicines they need. Here’s why.
Bringing Commercial Scale Manufacturing to Cell Therapies
Many pharma and biotech organizations today are developing cell and gene therapies at a small scale, in a lab setting, and submitting this open and usually manual process as part of their regulatory submission. But these processes are a far cry from what’s needed to produce them at scale, and once they get regulatory approval, many organizations will find themselves going back to the drawing board to create a manufacturing process suitable for commercialization, and in many cases will need to update their submission -- costing them time and money. Even some of the considerations that need to be addressed in terms of supply chain, raw material variability, automation and documentation can be very different.
For example: In the approvals that have occurred to date (Kymriah and Yescarta), cell and gene therapy manufacturing processes still are not fully automated. In clinical centers, from the time a patient’s cells are collected by apheresis, and put through all the production steps, and through to reintroduction to the patient, there can be upwards of 20 manual interventions in the process requiring skilled technical staff. Each and every one of those manual steps is a potential for contamination.
To reduce risk, organizations will need to adopt newer technologies such as automation, digitization, simplification and closed systems when they tackle standardization and optimization of commercial-scale processes.
The establishment of the center in China will connect organizations with GE Healthcare Life Sciences, an established, reputable expert in the biomanufacturing industry. Together, we will design, standardize, leverage, and master commercial scale manufacturing processes of cell and gene therapies so they can be safely delivered to patients sooner.
A Significant Milestone…
I’m really optimistic about this milestone because it means we will be able to bring important technology and process development capabilities, plus training, professional upskilling and standardization support to this rapidly evolving industry—right where a lot of the action is happening.
During my time at GE Healthcare, I’ve met with our customers responsible for researching and manufacturing these transformative treatments for patients. I have heard their stories about the transformation that cell therapy has enabled in patient’s lives — and it’s impossible to not be excited. As a critical cog in the wheel of biomanufacturing, we have been able to watch and help support the realization of medicines and treatments that were once nothing more than concepts. But today, these therapies are real, and are having a tangible impact on patients’ lives.
….Part of a Global Cause
I’ll note that the Center in Shanghai is just the beginning. With our proven track record in mAbs and vaccines and our reputation as a high-quality global partner in the biopharmaceutical industry, we’re excited to help companies around the world develop and position technologies for global scale manufacturing. So we’ll look to replicate these centers of excellence like the one in Shanghai in other locations around the world.
It’s part of GE Healthcare’s mission to help patients. To advance precision health. To help improve health outcomes and enhance the quality of life for millions of people around the globe. And I’m loving every second of being a small part of that mission!